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NCT04742660 Clinical Trial

The Effect of Glycyrrhizin on the Occurrence of Postoperative Nausea and Vomiting

Postoperative Nausea Clinical Trial

Official title:
The Effect of Administration of Glycyrrhizin During Induction Period on the Occurrence of Postoperative Nausea and Vomiting After Breast Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04742660
Other study ID # KUH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 11, 2021
Est. completion date March 10, 2022

Study information
Verified date May 2022
Source Konkuk University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators investigate the association between the administration of glycyrrhizin during induction of general anesthesia and the occurrence of postoperative nausea and vomiting (PONV) in patients undergo breast surgery

Description:

Postoperative nausea and vomiting (PONV) is one of a common complication after general anesthesia with 30-50% of incidence, increased up to 80% in high risk group. The risk factors of PONV include women population, the previous history of PONV, motion sickness in usual life, non-smoker, exposure to inhalants, perioperative opioid and laparoscopic surgery. Women population is a strong risk factor of PONV. Although perioperative management of PONV based on a guideline has been done in a lot of medical centers worldwide, the incidence of PONV is still reported relatively high. The main ingredient of Glycyrrhizin is liquorice which has been used as antispasmodics, antiemetics or treatment for gastric ulcer in oriental medicine. Utilizing these effects of liquorice, the investigators investigate whether the addition of glycyrrhzin to conventional antiemetics is effective to decrease the incidence of PONV and improvement of severity of PONV.

Recruitment information / eligibility
Status Completed
Enrollment 224
Est. completion date March 10, 2022
Est. primary completion date March 8, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria: - participants scheduled to undergo breast surgery aged 20 and above Exclusion Criteria: - aldosteronism - electrolyte imbalance - myopathies - drug addiction or suspected - bowel disease - allergy to drugs - smoker - taking any medications

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ammonium Glycyrrhizinate
In control group, we assess the incidence and severity of PONV when participants are aministered ramosetron and placebo. In intervention group, the outcomes are assessed as a result of administration of ramosetron and glycyrrhizin.

Locations
Country Name City State
Korea, Republic of Konkuk University Medical Center Seoul Seoul-T'ukpyolshi

Sponsors (1)
Lead Sponsor Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary the incidence of postoperative nausea and vomiting (PONV) assessing the incidence of postoperative nausea and vomiting with ordinal scale (0=none, 1=nausea, 2=retching, 3= vomiting) up to 24 hours after discharge from postanesthetic care unit (PACU)
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